Ato-oxy + Oxygen for Sleep Apnea in Down Syndrome
(EDIT OSA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial seeks better treatments for obstructive sleep apnea (OSA) in individuals with Down syndrome, a condition where breathing repeatedly stops and starts during sleep. The study will test two treatments: one group will receive a combination of medications, atomoxetine and oxybutynin (ato-oxy), while another group will receive either ato-oxy or oxygen therapy, depending on individual needs. This method is known as Endotype Directed Treatment. Individuals with Down syndrome who experience breathing issues during sleep may be suitable candidates for this study. The trial will evaluate the impact of these treatments on sleep apnea severity, quality of life, behavior, and cognitive function after 12 months. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, aiming to understand its benefits for more patients.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using MAO inhibitors. It's best to discuss your current medications with the study team to see if they might affect your eligibility.
What is the safety track record for these treatments?
Research shows that the combination of atomoxetine and oxybutynin, known as "ato-oxy," is generally safe for people with Down syndrome who have obstructive sleep apnea (OSA). Studies have found that this combination significantly reduces the severity of OSA. Researchers have tested it in both adults and children with Down syndrome.
Earlier trials found ato-oxy effective and safe for treating OSA. While it may not work for everyone, it has shown promise without many serious side effects. Most side effects, if they occur, are minor and manageable.
For the oxygen therapy part, oxygen is often used for OSA and is generally considered safe. Its successful use in various conditions has established its safety.
In summary, past studies have shown both ato-oxy and oxygen therapies to be safe. Participants in this clinical trial can expect that these treatments have been tested before in similar groups and have proven to be safe and effective.12345Why are researchers enthusiastic about this study treatment?
Most treatments for sleep apnea in Down syndrome, like continuous positive airway pressure (CPAP) machines, focus on keeping the airway open during sleep. But the new approach using a combination of atomoxetine and oxybutynin (ato-oxy) targets the condition differently by addressing the neural pathways that control muscle tone in the airway. Researchers are excited because this could offer a more tailored treatment option, potentially reducing the need for cumbersome equipment and improving the quality of sleep for those affected. Additionally, the endotype-directed treatment option personalizes therapy based on individual sleep study results, which could increase effectiveness by matching the right treatment to the right patient.
What evidence suggests that this trial's treatments could be effective for sleep apnea in Down syndrome?
Research shows that a combination of two medications, atomoxetine and oxybutynin (called "ato-oxy"), might help treat obstructive sleep apnea (OSA) in people with Down syndrome. Studies have found that ato-oxy can improve breathing during sleep for some individuals in this group, though it doesn't work for everyone. In this trial, participants in one arm will receive the combination of atomoxetine and oxybutynin (ato-oxy) once nightly.
Oxygen therapy is another option that has been effective for some people with OSA, especially those with mild cases. In the other arm of this trial, participants will receive either ato-oxy or oxygen nightly, based on their baseline sleep study and OSA characteristics (OSA endotype). Both treatments have potential, but their effectiveness can depend on individual factors.678910Who Is on the Research Team?
Daniel Combs, MD
Principal Investigator
University of Arizona
Are You a Good Fit for This Trial?
This trial is for children and adults aged 6-17 with Down syndrome and obstructive sleep apnea (OSA). Participants must have a confirmed diagnosis of both conditions. The study excludes individuals who do not meet the age requirement or have other health issues that could interfere with the treatment or data collection.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either atomoxetine and oxybutynin (ato-oxy) or oxygen therapy based on their OSA endotype
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Endotype Directed Treatment
Trial Overview
The study tests two treatments for OSA in people with Down syndrome: atomoxetine combined with oxybutynin ('ato-oxy') versus oxygen therapy. It uses precision medicine to determine which treatment might work best based on individual OSA causes, comparing effectiveness over a year.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants receive either atomoxetine and oxybutynin (ato-oxy) or oxygen nightly. Participants receive the treatment expected to be most beneficial to them based on their baseline sleep study and OSA characteristics (OSA endotype).
All participants receive the combination of atomoxetine and oxybutynin (ato-oxy) once nightly
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Arizona
Lead Sponsor
Patient-Centered Outcomes Research Institute
Collaborator
Citations
The combination of atomoxetine and oxybutynin for ... - PubMed
We evaluated the effectiveness of atomoxetine and oxybutynin (ato-oxy) to treat OSA in children with Down syndrome.
Endotype DIrected Treatment for OSA in Down Syndrome
The combination of 2 medications, atomoxetine and oxybutynin ("ato-oxy") is a promising treatment for OSA in people with Down syndrome, but ato- ...
Comparing Precision Medicine Versus Uniform Therapy To ...
This study compares the clinical effectiveness of atomoxetine-oxybutynin therapy with precision medicine-guided therapy for treatment of ...
The combination of atomoxetine and oxybutynin for the ...
We evaluated the effectiveness of atomoxetine and oxybutynin (ato-oxy) to treat OSA in children with Down syndrome.
Outcomes in Children with Down Syndrome and Mild ...
Nasal steroids, oral anti-leukotrienes and supplemental oxygen are effective in the treatment of mild obstructive sleep apnea (OSA) in otherwise healthy ...
Atomoxetine and Oxybutynin in Obstructive Sleep Apnea
The combination of atomoxetine and oxybutynin greatly reduces obstructive sleep apnea severity. A randomized, placebo-controlled, double-blind crossover trial.
The combination of atomoxetine and oxybutynin for the ...
The combination of atomoxetine and oxybutynin is a promising treatment for obstructive sleep apnea in adults with Down syndrome and may be particularly ...
0796 Safety and efficacy of the combination of atomoxetine ...
Children with Down syndrome (DS) are at very high risk for obstructive sleep apnea (OSA), with a prevalence of OSA of 50-79%.
Medications for Obstructive Sleep Apnea to Improve ...
This is an open-label study of the combination of atomoxetine and oxybutynin (ato-oxy) in children with Down syndrome and obstructive sleep ...
NCT04115878 | Medications for Obstructive Sleep Apnea ...
This is a randomized, double blind, cross-over study of the combination of atomoxetine and oxybutynin (ato-oxy) in children with DS and OSA documented by ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.